MAUDE Adverse Event Report: ARKRAY FACTORY, INC. RELION PRIME BLOOD GLUCOSE TEST SYSTEM

Model Number	701103
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Coma (2417)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected. retain strips of specified lot were tested with reference meter and passed testing with no failures detected.Actual product was not returned.If either meter or strips is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Caller reported that the glucose meter is new, and she purchased 200 test strips.The caller then stated that she had been in the hospital because of a diabetic coma.The rep asked if the hospital visit was in relation to the meter and the customer stated, "well the meter didn't work, i know that much".The rep then asked more about the adverse event and the caller simply stated she went into a coma and she didn't even know she was a diabetic.The caller was uncooperative in answering any more questions regarding the event.Caller indicated the hospital visit was in relation to the meter "not working," but would not elaborate on the event.Arkray attempted to gather information and request the return of meter from the customer, but customer refused and discarded product.

• Brand Name: RELION PRIME BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• MDR Report Key: 8687818
• Report Number: 1832816-2019-00011
• Device Sequence Number: 3029861
• Product Code: NBW
• UDI-Device Identifier: 00605388022943
• UDI-Public: (01)00605388022936,(01)00605388022943
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K091102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/17/2020
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 040219A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention